G/SPS/GEN/1808  
6 July 2020 
(20-4639) Page: 1/4 
Committee on Sanitary and Phytosanitary Measures  Original:  Spanish  
 
  
MODIFICATION OF EUROPEAN UNION MRLS FOR PHYTOSANITARY PRODUCTS:  
MANCOZEB ( G/SPS/N/EU/384 ) – SPECIFIC TRADE CONCERN OF  
COLOMBIA AND ECUADOR  
COMMUNICATION FROM COLOMBIA AND ECUADOR  
The following commun ication, received on 3 July 2020, is being circulated at the request of the 
delegations of Colombia  and Ecuador . 
 
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1.  Colombia and Ecuador wish to offer comments and express their concern regarding the 
measure notified by the European Union (EU) in document G/SPS/N/EU/384  of 24 April 2020 
relating to the non -renewal of the approval of the use of the active substance m ancozeb, given 
that this substance is vital for pest control in a wide variety of crops, including bananas, which are 
the main export of Colombia and Ecuador to the EU.  
2.  By me ans of this communication, we wish to bring to the attention of the  European Commission 
and WTO Members an issue that we consider  to be of the utmost importance for the global banana 
sector and, in particular, for Colombia and Ecuador . We would appreciate our comments on this 
issue being taken into account , with a view to  ensuring  the continued protection of consumer 
health and,  in parallel , avoiding any effects on the agricultural trade of Latin American countries, 
for the reasons set out below . 
3.  The EU has  been adopting measures that have resulted  in the non -renewal of the approval of 
the use of crop protection products, thereby  affecting the exports of its trading partners . Measures 
on the suspension or non -renewal of the approval of the use and, th us, marketing of numerous 
active substances , as well as the subsequent reduction of their maximum residue levels (MRLs) to 
the minimum detection level , are being taken without any sound scientific evidence and without 
proof that such measures are the least tra de-restrictive means of achieving an appropriate level of 
protection for consumers . 
4.  The m ancozeb  compound  was developed in Europ e almost 60 years ago to protect crops . It is 
currently registered for more than  70 crops and over 400 approved uses across the world . It is one 
of the most robust  active substances in that there have been no reports since its registration of a 
loss of sensitivit y, of resistance , or of any harmful effects on treated crops . This is owing to  the 
substance's multi -site properties , which enable it to attack different parts of the fungus without 
creating resistance . As a result , when used as prescribed in the labelling , it is considered  to be  a 
key tool in fungus control programmes . 
5.  This compound is crucial for pest management and preventing resistance because, owing to the 
tropical climate in countries like Ecuador and Colombia , pest and disease behaviour follow s 
patterns that are very different from those prevailing in countries wit h four seasons, such as those 
in the EU, meaning that the use of certain active substances  such as  mancozeb and its formula ted 
products  is vital in agricultural production . Prohibiting the use of mancozeb could have a very 
significant  economic  impact on sm all-, medium -, and large -scale producers in our countries, as 
well as on consumers in the EU , because  the supply  of our food would be affected . G/SPS/GEN/1808  
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  6.  In Colombia and Ecuador , the use of the active substance m ancozeb is essential in agricultural 
production for pr otecting banana crops against pests and diseases such as Black Sigatoka , a 
devastating disease that attacks the foliar system and is caused by the fungus Mycosphaerella 
fijiensis . This fungus is extremely dangerous and is classed as very high risk by the Fungicide 
Resistance Action Committee (FRAC) on account of its ability to adapt rapidly to climatic changes 
and, above all, its inherent capacity to develop resistance to various che mical groups of fungicides . 
Not only is m ancozeb a fungicid al compound, but it is also a n integrated  management tool that 
contributes to reducing the risk of fungicide resistance and maintaining the sustainability of the 
agricultur al sector . 
7.  Black Sigatoka  currently shows resistance to three different chemical groups of fungicides used, 
which is severely limiting the control of the disease . This is why the use of mancozeb is of such 
importance in banana -producing countries . Recently, the EU also banned the marketing of 
chlorothalonil (through document "Chlorothalonil -SANTE/10186/2018 Rev . 1 – 22 March  2019, 
Final renewal report for the active substance Chlorothalonil") , which is the main tool for controlling 
Black Sigatoka . In this regard, banning mancozeb ( an alternative compound ) would leave 
banana -producing countries without any phytosanitary tools for control ling this disease, resulting 
in significant economic losses in Latin American countries, particularly in Colombia and Ecuador, 
with bananas being the main export product of both countries . 
8.  In addition,  owing to the limited number of chemical groups of fungicid es available  or 
alternatives for the control of Black Sigatoka in banana crops, the risk of the fungus developing 
resistance is extremely high . Mancozeb  has been used effectively, with no signs of resistance 
reported, thereby  reduc ing the amount and frequency of the applications of this compound on 
crops . There is evidence that the absence of mancozeb, combined with the lack of products having 
a similar effect, could cause the resistance shown by the fungus to worsen  to the point of no  
return, making phytosanitary management difficult . This would have catastrophic consequences 
for banana crops  and the agricultural producers whose livelihoods depend on them.  
9.  Many regions across the world produce bananas and they are a key part of agricultural exports . 
As a result, the crop must be properly managed in technical and phytosanitary terms and it must 
be environmentally sustainable . The absence of any of these pillars could mean that banana 
production would no longer be viable . 
10.  A review of the EU's draft regulation shows that the scientific justification for the changes  or 
amendments to regulations on the approval of the use of active substances is becoming less 
relevant , given that,  for example, the decision on the non -renewal of the approval of the use of 
mancozeb has been taken by applying  a hazard -based approach and the precautionary principle . 
This means that the lack of information and sufficient scientific studies in the EU required for 
making a risk - and science -based decision has been ignored , contrary to the provisions of the 
WTO SPS Agreement . 
11.  In Colombia and Ecuador 's view , it is a source of concern that the European Food Safety 
Authority ( EFSA), in its final document on the evaluation of the active ingredient m ancozeb and 
the corresponding peer review, refers to developmental toxicity and genotoxici ty, yet does so  
without conclusive studies . Evaluations carried out by agencies such as the  United States 
Environmental Protection Agency ( EPA) make the same reference , although the EPA highlights the 
need to conduct  studies on developmental neurotoxicity attributed to ethylenethiourea (ETU) in 
order to reach sound  conclusions . 
12.  In this regard , it is our  understand ing that the EFSA decided not to approve  the renewal of the 
use of mancozeb because it classifies the active ingredient in "toxic for reproduction " category  1B 
and conside rs it to be an endocrine disruptor in humans and non -target  species . However, 
following the corresponding analysis of the evaluation carried out by the EFSA, we consider  that, 
given the reproductive toxicity hazard profile of mancozeb , it must be taken into account that it is 
more appropriate to classify mancozeb  in "toxic f or reproduction " category 2 , or even to refrain 
from classif ying it . Consequently , the toxicity classification of mancozeb must be decided on the 
basis of the active ingredient . G/SPS/GEN/1808  
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  13.   We consider  that the studies to be taken into account must comply with the an alytical and 
procedural  rigour  required by EU regulation s and the Codex  Alimentarius . Moreover, it should be 
highlighted that m ancozeb does not produce adverse effects in experimental species of mammal s 
or human s in doses and concentrations lower  than th ose at which it might be expected to see  
effects as a result of  systemic toxicity . Mancozeb has an effect on the thyroid hormonal system in 
a number of mammal species, but not in humans . However, thresholds and rev ersibility have been 
demonstrated . On this basis, we would be grateful  if the EU would take into account the comments 
made by Colombia and Ecuado r, with a view to classifying m ancozeb in "toxic for reproduction " 
category 2  and not as a significant endocrin e disruptor in humans . 
14.  Accordingly , we request the European Commission to take into account : (i) the results 
recorded in the annual reports issued by the EU -coordinated Control Programme  (EUCP), which 
demonstrate residue levels in fruit such as bananas tha t are lower than the established MR L; 
(ii) the information generated at a global level through residue test ing, which confirms  strict 
compliance with MRLs ; (iii) the established thresholds for mancozeb , particularly since  this is a 
requirement for the non-reduction of MRLs ; (iv) the recognition of the MRLs established in the 
Codex Alimentarius , since we consider that non-recognition  would imply disregard  for the work of 
the Codex Alimentarius  Commission , and also  for consumer health protection policies in countries 
like our own  that adopt Codex standards ; and (v) the analytical identifica tion of dithiocarb amate 
residu es, which is covered by the definition of CS2 single  residu e. 
15.  In light of the above , we consider  that the measure proposed by the EU is neither justifie d nor 
supported by sufficient  information to establish criteria for the acceptance or rejection of 
mancozeb . This is because, at the  scientific level, its adverse effect on health has not been clearly  
established , meaning that it is crucial for the EU to adopt a risk assessment approach in the 
analysis of this regulatory change, given that it lacks sufficient and conclusive scientific studies 
from EU Member States  to determine the various toxicological  aspects that may affect human 
health . There are even some preliminary findings that point to a safe use of mancozeb within the 
EU. 
16.  Furthermore, it should be noted that there are scientific opinions at the European level 
indicat ing that mancozeb is not an endocrine disruptor . On that basis, a scientifically sound 
evaluation would only be possible if sufficient time is granted to generate data from countries , in 
order to conduct a risk assessment with all available scientific studies that include the 
corresponding levels of exposure for determining the safety thresholds for mancozeb . 
17.  Colombia and Ecuador support  the decision  made by globally -recognized expert authorities to 
authorize  the registration of m ancozeb for the majority of approved uses , by adopting the 
necessary risk -mitigation  measures to ensure a safe use of the compound through labelling . We 
consider it highly inappropriate  that decisions regarding the reduction of MRLs or restrictions on 
the use of active compounds  continue to be made  solely on the basis of the precautionary 
principle , rather than through a full risk analysis  that would provide clear evidence on the 
compo und's danger to human health . 
18.  In light of this , Colombia  and Ecuador consider  that the draft technical regulation amending 
Regulation No. 1107/2009 of the European Union  – Non-renewal of mancozeb  – must be drawn up 
in line with the WTO SPS Agreement, particular ly with respect to the provisions of Article 2.2  (the 
SPS measure must be based on scientific princ iples) , Article 5.2 (in the assessment of risks, 
Members shall take into account : available scientific evidence ; banana production processes and 
methods in the countries that may be affected by the i mplementation  of the regulation ; and 
relevant inspection,  sampling and testing methods ) and Article 5.3 (Memb ers shall take into 
account as relevant economic factors : the potential damage in terms of los s of production or 
sales).  
19.  Moreover , with regard to the deadlines established in notification G/SPS/N/EU/384  of 
24 April 2020, we would be grateful if the EU could provide greater clarity regarding the timeframe 
for adoption of the measures . In this respect, we wish to recall that WTO Members must allow a 
reasonable interval of 36 months between the publication of technical regulatio ns and their entry 
into force , in order to allow time for producers in exporting Members, and particularly in 
developing countries, to adapt their products or production methods to the requirements of the 
importing Member . G/SPS/GEN/1808  
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  20.  In view of the arguments presente d, Colombia and Ecuador request the EU to renew the 
approval of mancozeb and maintain its MRLs as a risk management measure to protect  the health 
of consumers in the EU and facilitate trade for its partners, such as Colombia  and Ecuador . The 
ban and conseq uent reduction of MRLs in the EU for chlorothalonil and mancozeb (an alternative 
compound) would leave Black Sigatoka management and control programmes without any 
phytosanitary tools, resulting in highly regrettable consequences for the environment and th e 
economic sustainability of banana crops in all banana -producing countries . Such countries would 
also see social consequences, bearing in mind that in Colombia, for example, over 45,000 people 
directly and some 120,000  people  indirectly depend on the prod uction of bananas for export to the 
EU for their livelihoods . In Ecuador, the corresponding  figures stand at around 53,200  people  and 
560,000  people  respectively . 
21.  In addition , the health and scientific authorities in all countries, including Colombia and 
Ecuador, have been obliged  to focus on addressing the situation that has arisen as a result of the 
COVID -19 global health emergency . Similarly, key sectors such as food producer s, organizations 
and associations are making significant efforts to ensure biosecurity controls in the fruit and 
vegetable supply chain . This is reducing their capacity  to analyse draft regulatory measures and  
hence also to adjust production methods, and is creating additional burdens on international trade 
in food products and hampering worldwide economic recovery efforts, particularly in developing 
countries . 
22.  Colombia and Ecuado r therefore wish to highlight the difficulties  being experienced by 
Latin American countries in handling the many notifications concerning  amendments  to regulations 
on compounds and MRL s in the EU during the current COVID -19 global pandemic . The pandemic 
has become the greatest worldwide health challenge, for which reason we support the request to 
be submitted by over 30 countries, including Colombia and Ecuador , at the next 
WTO SPS Committee  meeting  through  document G/SPS/GEN/1778/Rev.2  relating to the 
suspension of the processes and entry into force of reductions of MRLs for plant protection 
products  in light of the COVID -19 pandemic . 
23.  We wish to emphasize  that the deadline for the receipt of comments  is normally a minimum of 
60 days (according to the WTO transparency pro cedure ), yet notifica tion G/SPS/N/EU/384  was 
circulated to all WTO Members on  24 April 2020 and the proposed deadline in the text for receipt 
of comments is 17 June 2020. In other words, this notification would  not be in compliance  with the 
60-day period recommended by the WTO . 
 
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